Excuses, Excuses: How ‘Delayed’ Confirmatory Trials Are Explained By FDA

US FDA currently reports about two dozen Accelerated Approval having ‘delays’ in the confirmatory trials. COVID is one factor in some – and the agency also appears to be clearing out some of the others.

Excuses magnifying glass
• Source: Alamy

During a Reagan-Udall Foundation meeting tied to the 30th anniversary of the US Food & Drug Administration’s Accelerated Approval pathway, earlier this month, agency officials came armed with data to help shape the narrative around the ongoing debate over potential reforms to the program.

The data help, in part, to counter the argument that there are countless products that gain approval using the accelerated...

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